ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 6: Resource requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 6.4.2: Equipment requirements

What does 6.4.2 require?

The laboratory shall be able to obtain the equipment its activities need in order to be carried out correctly. If equipment is used beyond the laboratory's permanent control or outside the manufacturer's performance specification, management shall make sure this document's requirements are still satisfied. Each item that can affect activities shall carry a unique identification and appear in a register. Equipment shall be looked after and replaced when necessary so that results remain of good quality.

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